NCT05589038终止不适用
A Randomized, Evaluator-Blinded, Clinical Evaluation of a Regimen of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Tolerability and Impact on Skin Barrier and Microbiome on Newborns
Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change from Baseline in Parental Assessment Score
研究概览
简要总结
The purpose of this study is to demonstrate the tolerance of a baby wash/shampoo alone and the tolerance of a regimen of a baby wash/shampoo and baby lotion in a newborn population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Baby and Parent:
- •Baby medically determined to be in overall good health and eligible for study participation. Parent determined to be in generally good health and able to participate fully in the study
- •For Baby only:
- •Healthy, full-term, newborns 0 - 28 days old at start of study, (both vaginal and Caesarean mode of delivery may be included, 37+ weeks gestation)
- •Fitzpatrick Skin Types I - VI
- •For Parent only:
- •18 years of age or older
- •Biological, legal guardian and primary caregiver of the baby participant (must be able to present proof of guardianship [that is, birth certificate along with valid identification {ID} of parent, hospital records, insurance card, et cetera {etc.}])
- •Able to read, write, speak, and understand english
- •Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- •Has to have access to internet to be able to complete questionnaires and diaries
- •Intends to successfully complete the study and is willing and able to follow the participant responsibilities
排除标准
- •For Baby and Parent:
- •Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
- •Is taking medications that would mask an adverse event (AE) or influence the study results, including: immunosuppressive and steroidal drugs within 3 months before Visit 1 and during the study; non-steroidal anti-inflammatory drugs within 5 days before Visit 1 and during the study; antihistamines within 2 weeks before Visit 1 and during the study; systemic or topical over-the-counter (OTC) or prescription medications that, in the principle investigator (PI)'s judgement, will affect skin condition or interfere with study evaluation (example, antibiotics). Use of acetaminophen as needed is acceptable if it was instructed by the baby's pediatrician. Child vitamins are allowed
- •Has a history of or a concurrent health condition/situation which, in the opinion of the PI, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
- •Is simultaneously participating in any other type of study or has participated in a study within the past 14 days
- •Is an employee/contractor or immediate family member of the PI, study site or sponsor
- •For Baby only:
- •Presents with a skin condition that may influence the outcome of the study (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
- •Either biological parent or a sibling has clinically determined atopic dermatitis or asthma
- •Clinical grade greater than 0 for rash/irritation or greater or equal to 1 for any of the other clinically assessed parameters
- •For Parent only:
- •Is self-reported to be pregnant or planning to become pregnant during the study
结局指标
主要结局
Change from Baseline in Parental Assessment Score
时间窗: Baseline (Day 0) up to Day 28
The parental assessment for the baby's skin will be performed for burning/stinging and itching on the scalp, face, arms, legs, and torso (chest and back together) on a 4-point scale of '0' (none) to '3' (severe). A decrease in scores indicates an improvement.
Change from Baseline in Clinical Assessment of Cutaneous Tolerance scores
时间窗: Baseline (Day 0) up to Day 28
The investigator will assess baby's scalp, face, arms, legs, and torso (chest and back) globally for the following parameters (that is, dryness, redness/erythema, rash/irritation, and tactile roughness) on a 4-point scale from '0' (none) to '3' (severe). A decrease in scores indicates an improvement.
次要结局
- Product Questionnaire as Assessed by Parent Participants(Day 28)
- Change from Baseline in Microbiome(Baseline (Day 0) up to Day 28)
- Change from Baseline in Skin pH(Baseline (Day 0) up to Day 28)
- Change from Baseline in Parentype Questionnaire(Baseline (Day 0) up to Day 28)
- Change from Baseline in Metabolome(Baseline (Day 0) up to Day 28)
- Weekly Diary Compliance(Day 1 through Day 28)
研究者
研究点 (2)
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